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4. Patient characteristics and acute cardiovascular event rates among patients with very high‐risk and non‐very high‐risk atherosclerotic cardiovascular disease

Author

Fonarow, Gregg C, Kosiborod, Mikhail N, Rane, Pallavi B, Nunna, Sasikiran, Villa, Guillermo, Habib, Mohdhar, Arellano, Jorge, Mues, Katherine E, Sun, Kainan, and Wade, Rolin L

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Cardiovascular, Heart Disease - Coronary Heart Disease, Heart Disease, Prevention, Good Health and Well Being, Adolescent, Atherosclerosis, Cardiovascular Diseases, Cohort Studies, Humans, Retrospective Studies, Risk Assessment, Stroke, United States, atherosclerotic cardiovascular disease, major cardiovascular events, real-world evidence, very high-risk, Cardiorespiratory Medicine and Haematology, Cardiovascular System & Hematology, Cardiovascular medicine and haematology
Abstract

BackgroundThe risk for subsequent major cardiovascular (CV) events among patients with very high-risk (VHR) atherosclerotic CV disease (ASCVD) remains to be fully elucidated.HypothesisWe assessed the characteristics and major CV event rates of patients with VHR versus non-VHR ASCVD in a real-world setting in the United States (US), hypothesizing that patients with VHR ASCVD would have higher CV event rates.MethodsThis was a retrospective cohort study conducted from January 01, 2011, to June 30, 2018, in the US using the Prognos LDL-C database linked to the IQVIA PharMetrics Plus® database supplemented with the IQVIA prescription claims (Dx/LRx) databases. Patients were ≥18 years old and had  ≥2 non-ancillary medical claims in the linked databases at least 30 days apart. The study was conducted in 2 stages: (1) identification of patients with ASCVD who met the definition of VHR ASCVD and a matched cohort of non-VHR ASCVD patients using the incidence density sampling (IDS) approach; (2) estimation of the occurrence of major CV events.ResultsAmong patients with ≥1 major ASCVD event (N=147,679), most qualified as VHR ASCVD (79.5%). There were 115,460 patients each in IDS-matched VHR and non-VHR ASCVD cohorts. The composite myocardial infarction/ischemic stroke event rates in the VHR and non-VHR ASCVD cohorts were 8.04 (95% confidence interval [95% CI]: 7.87-8.22) and 0.82 (95% CI: 0.77-0.88) events per 100 patient-years, respectively, during the 1-year post-index period.ConclusionsMost patients with ≥1 previous major ASCVD event treated in real-world US clinical practice qualified as VHR ASCVD. Patients with VHR ASCVD had much higher rates of major CV events versus non-VHR ASCVD patients.

Published
2021

7. Atherosclerotic Cardiovascular Disease Events in Adults With CKD Taking a Moderate- or High-Intensity Statin: The Chronic Renal Insufficiency Cohort (CRIC) Study

Author

Poudel, Bharat, Rosenson, Robert S., Bittner, Vera, Gutiérrez, Orlando M., Anderson, Amanda H., Woodward, Mark, Deo, Rajat, Carson, April P., Mues, Katherine E., Dluzniewski, Paul J., Jaar, Bernard G., Lora, Claudia M., Taliercio, Jonathan, Muntner, Paul, and Colantonio, Lisandro D.

Published
2021
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15. Use of Guideline-Recommended Risk Reduction Strategies Among Patients With Diabetes and Atherosclerotic Cardiovascular Disease: Insights From Getting to an Improved Understanding of Low-Density Lipoprotein Cholesterol and Dyslipidemia Management (GOULD)

Author

Arnold, Suzanne V., de Lemos, James A., Rosenson, Robert S., Ballantyne, Christie M., Liu, Yuyin, Mues, Katherine E., Alam, Shushama, Elliott-Davey, Mary, Bhatt, Deepak L., Cannon, Christopher P., and Kosiborod, Mikhail

Published
2019
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16. Evaluating the Effectiveness of mRNA-1273.815 Against COVID-19 Hospitalization Among Adults Aged ≥ 18 Years in the United States

Author

Wilson, Amanda, Rahai, Neloufar, Beck, Ekkehard, Beebe, Elisha, Conroy, Brian, Esposito, Daina, Govil, Priya, Kopel, Hagit, Lu, Tianyi, Mansi, James, Marks, Morgan A., Mues, Katherine E., Shah, Rohan, Skornicki, Michelle, Sun, Tianyu, Toyip, Astra, Yousefi, Mitra, Martin, David, and Araujo, Andre B.

Abstract

Introduction: In September 2023 the Food and Drug Administration (FDA) approved an updated mRNA COVID-19 vaccine targeting the XBB.1.5 sublineage. This study evaluates the effectiveness of mRNA-1273.815, a 2023–2024 Omicron XBB.1.5-containing mRNA COVID-19 vaccine in preventing COVID-19-related hospitalizations and medically attended COVID-19 in US adults aged ≥ 18 years. Methods: This observational, matched cohort study used medical and pharmacy claims data from HealthVerity. Adults vaccinated with mRNA-1273.815 between September 12, 2023, and December 31, 2023, were followed through January 26, 2024. Vaccinated individuals were matched with individuals unvaccinated with any 2023–2024 COVID-19 vaccine on demographic and clinical characteristics. The primary and secondary outcomes were COVID-19 hospitalization and medically attended COVID-19, respectively. Inverse probability of treatment weighting and Cox proportional hazards regression were utilized to estimate vaccine effectiveness (VE). Results: The study included 1,272,161 vaccinated individuals matched 1:1 with unvaccinated individuals, with a maximum follow-up of 128 (median 84) days. The VE against COVID-19 hospitalization was 51% (95% confidence interval [CI]: 48–54%). Subgroup analyses showed a VE of 56% (95% CI 51–61%) among adults ≥ 65 years and 46% (95% CI 39–52%) in immunocompromised adults. For medically attended COVID-19, the VE was 25% (95% CI 24–27%). Time-varying analyses showed that while VE declined over time, VE remained significant. Conclusion: During the 2023–2024 respiratory season, the mRNA-1273.815 vaccine significantly protected against COVID-19-related hospitalizations and medically attended COVID-19 across diverse adult populations and demonstrated durability of the effect. These results support the continued use of updated COVID-19 vaccines to mitigate severe outcomes and maintain public health safety.

Published
2024
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17. Real-world comparative effectiveness of mRNA-1273 and BNT162b2 vaccines among immunocompromised adults identified in administrative claims data in the United States

Author

Mues, Katherine E., primary, Kirk, Brenna, additional, Patel, Deesha A., additional, Gelman, Alice, additional, Chavers, L. Scott, additional, Talarico, Carla A., additional, Esposito, Daina B., additional, Martin, David, additional, Mansi, James, additional, Chen, Xing, additional, Gatto, Nicolle M., additional, and Van de Velde, Nicolas, additional

Published
2022
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19. Real-world comparative effectiveness of mRNA-1273 and BNT162b2 vaccines among immunocompromised adults in the United States

Author

Mues, Katherine E., primary, Kirk, Brenna, additional, Patel, Deesha A., additional, Gelman, Alice, additional, Chavers, Scott, additional, Talarico, Carla, additional, Esposito, Daina B., additional, Martin, David, additional, Mansi, James, additional, Chen, Xing, additional, Gatto, Nicolle M., additional, and Van de Velde, Nicolas, additional

Published
2022
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21. Use of lipid‐lowering therapies in patients with chronic kidney disease and atherosclerotic cardiovascular disease: 2‐year results from Getting to an imprOved Understanding of Low‐Density lipoprotein cholesterol and dyslipidemia management (GOULD)

Author

Shaik, Aleesha, Kosiborod, Mikhail, de Lemos, James A., Gao, Qi, Mues, Katherine E., Alam, Shushama, Bhatt, Deepak L., Cannon, Christopher P., Ballantyne, Christie M., and Rosenson, Robert S.

Subjects
LDL cholesterol, CHRONIC kidney failure, CARDIOVASCULAR diseases, CHRONICALLY ill, CARDIOVASCULAR diseases risk factors
Abstract

Background: Chronic kidney disease (CKD) is a known risk factor of atherosclerotic cardiovascular disease (ASCVD). Per the 2018 American Heart Association/American College of Cardiology cholesterol guidelines, high‐risk ASCVD patients with CKD and low‐density lipoprotein cholesterol (LDL‐C) levels ≥ $\ge $ 70 mg/dL should take a high‐intensity statin with ezetimibe and/or a proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i). Objective/Methods: We examined the changes in use of lipid lowering therapies (LLT) over two years in 3304 patients with ASCVD and CKD in the Getting to an imprOved Understanding of Low‐Density Lipoprotein Cholesterol and Dyslipidemia Management (GOULD) observational cohort study. Results: Of those with eGFR <60 ml/min/1.73 m2, 21.6% (171/791) had intensification of LLT while 10.4% (82/791) had de‐escalation of LLT. Notably, 61.6% (487/791) had no change in LLT regimen over 2 years. Statin use was 83.2% (785/944) at baseline and 80.1% (634/791) at 2 years. Statin/ezetimibe use increased from 2.9% (27/944) to 4.9% (39/791). Statin discontinuation at 2 years was greater with lower eGFR levels across all cohorts. Conclusion: Despite the recommendations of multiscociety guidelines, statin use, while high, is not ubiquitous and rates of high‐intensity statin and ezetimibe use remain low in patients with CKD. There remains a significant opportunity to optimize LLT and achieve atheroprotective cholesterol levels in the CKD population. [ABSTRACT FROM AUTHOR]

Published
2022
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23. Factors Associated With PCSK9 Inhibitor Initiation Among US Veterans

Author

Derington, Catherine G., primary, Colantonio, Lisandro D., additional, Herrick, Jennifer S., additional, Cook, James, additional, King, Jordan B., additional, Rosenson, Robert S., additional, Poudel, Bharat, additional, Monda, Keri L., additional, Navar, Ann Marie, additional, Mues, Katherine E., additional, Stevens, Vanessa W., additional, Nelson, Richard E., additional, Vanneman, Megan E., additional, Muntner, Paul, additional, and Bress, Adam P., additional

Published
2021
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26. Atherosclerotic Risk and Statin Use Among Patients With Peripheral Artery Disease

Author

Colantonio, Lisandro D., primary, Hubbard, Demetria, additional, Monda, Keri L., additional, Mues, Katherine E., additional, Huang, Lei, additional, Dai, Yuling, additional, Jackson, Elizabeth A., additional, Brown, Todd M., additional, Rosenson, Robert S., additional, Woodward, Mark, additional, Muntner, Paul, additional, and Farkouh, Michael E., additional

Published
2020
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27. 1429-P: Use of Guideline-Recommended Risk-Reduction Strategies among Patients with Type 2 Diabetes and Established ASCVD: A 1-Year Update from Getting to an Improved Understanding of Low-Density Lipoprotein Cholesterol and Dyslipidemia Management (GOULD)

Author

KOSIBOROD, MIKHAIL N., primary, ARNOLD, SUZANNE V., additional, DELEMOS, JAMES, additional, ROSENSON, ROBERT S., additional, BALLANTYNE, CHRISTIE M., additional, LIU, YUYIN, additional, MUES, KATHERINE E., additional, ALAM, SHUSHAMA, additional, BHATT, DEEPAK L., additional, and CANNON, CHRISTOPHER, additional

Published
2020
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30. 10.1177_1358863X19871100_Supplemental_tables_and_figures – Supplemental material for Trends in statin utilization among adults with severe peripheral artery disease including critical limb ischemia in an integrated healthcare delivery system

Author

Reynolds, Kristi, Mues, Katherine E, Harrison, Teresa N, Qian, Lei, Songyue Chen, Hsu, Jin-Wen Y, Philip, Kiran J, Monda, Keri L, Reading, Stephanie R, and Somjot S Brar

Subjects
FOS: Clinical medicine, Cardiology, 110323 Surgery
Abstract

Supplemental material, 10.1177_1358863X19871100_Supplemental_tables_and_figures for Trends in statin utilization among adults with severe peripheral artery disease including critical limb ischemia in an integrated healthcare delivery system by Kristi Reynolds, Katherine E Mues, Teresa N Harrison, Lei Qian, Songyue Chen, Jin-Wen Y Hsu, Kiran J Philip, Keri L Monda, Stephanie R Reading and Somjot S Brar in Vascular Medicine

Published
2019
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31. Ischemic Event Rates in Very-High-Risk Adults

Author

Colantonio, Lisandro D., primary, Shannon, Erin D., additional, Orroth, Kate K., additional, Zaha, Rebecca, additional, Jackson, Elizabeth A., additional, Rosenson, Robert S., additional, Exter, Jason, additional, Mues, Katherine E., additional, and Muntner, Paul, additional

Published
2019
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32. Trends in statin utilization among adults with severe peripheral artery disease including critical limb ischemia in an integrated healthcare delivery system

Author

Reynolds, Kristi, primary, Mues, Katherine E, additional, Harrison, Teresa N, additional, Qian, Lei, additional, Chen, Songyue, additional, Hsu, Jin-Wen Y, additional, Philip, Kiran J, additional, Monda, Keri L, additional, Reading, Stephanie R, additional, and Brar, Somjot S, additional

Published
2019
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36. Adherence to Statin Therapy Among US Adults Between 2007 and 2014

Author

Colantonio, Lisandro D., primary, Rosenson, Robert S., additional, Deng, Luqin, additional, Monda, Keri L., additional, Dai, Yuling, additional, Farkouh, Michael E., additional, Safford, Monika M., additional, Philip, Kiran, additional, Mues, Katherine E., additional, and Muntner, Paul, additional

Published
2019
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39. How well can familial hypercholesterolemia be identified in an electronic health record database?

Author

Mues,Katherine E, Bogdanov,Alina N, Monda,Keri L, Yedigarova,Larisa, Liede,Alexander, Kallenbach,Lee, Mues,Katherine E, Bogdanov,Alina N, Monda,Keri L, Yedigarova,Larisa, Liede,Alexander, and Kallenbach,Lee

Abstract

Katherine E Mues,1 Alina N Bogdanov,2 Keri L Monda,1 Larisa Yedigarova,3 Alexander Liede,1 Lee Kallenbach2 1Center for Observational Research, Amgen Inc., Thousand Oaks, CA, USA; 2Practice Fusion, San Francisco, CA, USA; 3US Medical Affairs, Amgen Inc., Thousand Oaks, CA, USA Background: Familial hypercholesterolemia (FH) is a condition characterized by high cholesterol levels and increased risk for coronary heart disease (CHD) that often goes undiagnosed. The Dutch Lipid Network Criteria (DLNC) are used to identify FH in clinical settings via physical examination, personal and family history of CHD, in addition to the presence of deleterious mutations of the LDLR, ApoB, and PCSK9 genes. Agreement between clinical and genetic diagnosis of FH varies. While an ICD diagnosis code was not available for coding FH until 2016, Systematized Nomenclature of Medicine (SNOMED) clinical concept codes, including genetic diagnoses, for FH have been utilized in electronic health records (EHRs). Objective: To evaluate the concordance of identifying FH via SNOMED and ICD-10 CM codes vs the DLNC in an EHR database. Methods: Using the Practice Fusion EHR database, the sensitivity, specificity, positive predictive value (PPV), and negative predictive value were calculated comparing an FH cohort identified via SNOMED and ICD-10 CM codes to one identified via the DLNC. Results: Among 907,616 patients with hypercholesterolemia, 2,180 were identified as FH via SNOMED code (zero were identified via ICD-10 CM), 259 had a DLNC score 6–8 (probable FH), and 45 had a DLNC score >8 (definite FH). Compared to DLNC score >8, the sensitivity, specificity, and PPV of the FH SNOMED code were 84.4%, 99.4%, and 6.4%, respectively. Compared to DLNC score ≥6, the sensitivity was 36.8% and the specificity was 99.5% with a PPV of 18.7%. Conclusion: Compared to the clinical criteria for FH, identification of FH patients via SNOMED diagnosis codes had high sensitivity a

Published
2018

41. Trends in statin utilization among adults with severe peripheral artery disease including critical limb ischemia in an integrated healthcare delivery system.

Author

Reynolds, Kristi, Mues, Katherine E, Harrison, Teresa N, Qian, Lei, Chen, Songyue, Hsu, Jin-Wen Y, Philip, Kiran J, Monda, Keri L, Reading, Stephanie R, and Brar, Somjot S

Subjects
*PERIPHERAL vascular diseases, *ISCHEMIA, *CARDIOVASCULAR diseases, *ADULTS
Abstract

Evidence suggests that statin therapy in patients with peripheral artery disease (PAD) is beneficial yet use remains suboptimal. We examined trends in statin use, intensity, and discontinuation among adults aged ⩾ 40 years with incident severe PAD and a subset with critical limb ischemia (CLI) between 2002 and 2015 within an integrated healthcare delivery system. Discontinuation of statin therapy was defined as the first 90-day gap in treatment within 1 year following PAD diagnosis. We identified 11,059 patients with incident severe PAD: 31.1% (n = 3442) with CLI and 68.9% (n = 7617) without CLI. Mean (SD) age was 68.6 (11.3) years, 60.5% were male, 54.2% white, 23.2% Hispanic, and 16.2% black. Statin use in the year before diagnosis increased from 50.4% in 2002 to 66.0% in 2015 (CLI: 43.7% to 68.0%; without CLI: 53.1% to 64.2%, respectively). The proportion of patients on high-intensity statins increased from 7.3% in 2002 to 41.9% in 2015 (CLI: 7.2% to 39.4%; without CLI: 7.4% to 44.2%, respectively). Of the 40.5% (n = 4481) who were not on a statin in the year before diagnosis, 13.5% (n = 607) newly initiated therapy within 1 month (CLI: 10.1% (n = 150); without CLI: 15.3% (n = 457)). Following diagnosis, 12.5% (n = 660) discontinued statin therapy within 1 year (CLI: 15.5% (n = 202); without CLI: 11.5% (n = 458)). Although use of statins increased from 2002 to 2015, a substantial proportion of the overall PAD and CLI subpopulation remained untreated with statins, representing a significant treatment gap in a population at high risk for cardiovascular events and adverse limb outcomes. [ABSTRACT FROM AUTHOR]

Published
2020
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43. Use of the Medicare database in epidemiologic and health services research: a valuable source of real-world evidence on the older and disabled populations in the US.

Author

Mues, Katherine E., Liede, Alexander, Jiannong Liu, Wetmore, James B., Zaha, Rebecca, Bradbury, Brian D., Collins, Allan J., and Gilbertson, David T.

Subjects
MEDICAL databases, EPIDEMIOLOGY, OLDER people, HEALTH outcome assessment, ACQUISITION of data, HEALTH
Abstract

Medicare is the federal health insurance program for individuals in the US who are aged ≥65 years, select individuals with disabilities aged <65 years, and individuals with endstage renal disease. The Centers for Medicare and Medicaid Services grants researchers access to Medicare administrative claims databases for epidemiologic and health outcomes research. The data cover beneficiaries' encounters with the health care system and receipt of therapeutic interventions, including medications, procedures, and services. Medicare data have been used to describe patterns of morbidity and mortality, describe burden of disease, compare effectiveness of pharmacologic therapies, examine cost of care, evaluate the effects of provider practices on the delivery of care and patient outcomes, and explore the health impacts of important Medicare policy changes. Considering that the vast majority of US citizens ≥65 years of age have Medicare insurance, analyses of Medicare data are now essential for understanding the provision of health care among older individuals in the US and are critical for providing realworld evidence to guide decision makers. This review is designed to provide researchers with a summary of Medicare data, including the types of data that are captured, and how they may be used in epidemiologic and health outcomes research. We highlight strengths, limitations, and key considerations when designing a study using Medicare data. Additionally, we illustrate the potential impact that Centers for Medicare and Medicaid Services policy changes may have on data collection, coding, and ultimately on findings derived from the data. [ABSTRACT FROM AUTHOR]

Published
2017
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46. Cervical Cancer Screening Among Immigrants and Ethnic Minorities

Author

Johnson, Crista E., Johnson, Crista E., Mues, Katherine E., Mayne, Stephanie L., Kiblawi, Ava N., Johnson, Crista E., Johnson, Crista E., Mues, Katherine E., Mayne, Stephanie L., and Kiblawi, Ava N.

Abstract

OBJECTIVE: To systematically review all studies examining sociocultural factors influencing cervical cancer screening among immigrant and ethnic minorities in the United States along the theoretical framework of the Health Belief Model. MATERIALS AND METHODS: MEDLINE/PubMed, Cumulative Index to Nursing and Allied Health Literature, EMBASE, and Cochrane database searches were conducted searching for English language, US-based studies to examine minority and immigrant populations within the theoretical framework of the Health Belief Model. Fifty-five of more than 3,381 potentially relevant articles were included in the final analysis. RESULTS: Commonly held beliefs across several cultural groups emerged including the following: fatalistic attitudes, a lack of knowledge about cervical cancer, fear of Pap smears threatening one's virginity, as well as beliefs that a Pap smear is unnecessary unless one is ill. Beliefs unique to specific cultural groups included: body-focused notions among Hispanics, as childbirth, menses, sex, and stress were considered to play a role in one's susceptibility to cancer. African Americans identified administrative processes in establishing health care as barriers to screening, whereas Asian immigrants held a variety of misconceptions concerning one's susceptibility to cancer as well as stigmatization imposed by their own community and providers. CONCLUSION: Health care providers and policy makers must be cognizant of the various sociocultural factors influencing health-related beliefs and health care utilization among immigrant and ethnic minorities in the United States. Culturally relevant screening strategies and programs that address these sociocultural factors must be developed to address the growing disparity in cervical cancer burden among underserved, resource-poor populations in the United States.

Published
2008

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